Content about Orphan drugs

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

January 20, 2014

The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week.

NEW YORK — The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week. 

Both Mekinist and Tafinlar are only available in limited distribution, and Onco360 is one of the few pharmacies with access to both medications.

December 23, 2013

The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.

December 2, 2013

The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

JERUSALEM — The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

Teva said the drug, Treanda (bendamustine hydrochloride), received the designation for indolent B-cell non-Hodgkins lymphoma through October 2015 that has progressed during or within six months of treatment with a regimen containing Rituxan (rituximab), marketed by Genentech and Biogen Idec. The FDA gives orphan drug designation to treatments for diseases affecting fewer than 200,000 people in the United States.

November 22, 2013

The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

October 21, 2013

The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

October 9, 2013

The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

SILVER SPRING, Md. — The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

September 23, 2013

Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

PRINCETON, N.J. — Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.

October 26, 2012

A Swiss subsidiary of drug maker Celgene Corp. said its chemotherapy drug produced "significant" improvement in progression-free survival in patients with a deadly skin cancer that had spread elsewhere in the body.

BOUDRY, Switzerland — A Swiss subsidiary of drug maker Celgene Corp. said its chemotherapy drug produced "significant" improvement in progression-free survival in patients with a deadly skin cancer that had spread elsewhere in the body.

October 26, 2012

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

September 5, 2012

The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

The FDA announced the approval of Pfizer's Bosulif (bosutinib) for chronic myelogenous leukemia, or CML. According to the FDA, about 5,430 men and women will be diagnosed with CML this year.

The drug is designed for patients with chronic, accelerated or blast-phase Philadelphia chromosome-positive CML, who can't tolerate other therapies or for whom those therapies don't work.

August 6, 2012

The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

April 27, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

January 27, 2012

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

December 20, 2011

Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

PHOENIX — Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

April 20, 2011

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

March 25, 2011

The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

February 28, 2011

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

January 19, 2011

Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.

October 27, 2010

The Food and Drug Administration has approved a new usage for a blood cancer drug,...

July 18, 2010

Metabolex has entered an agreement to discover and develop Type 2 diabetes drugs with a...

July 11, 2010

A cancer drug made by Bristol-Myers Squibb and Otsuka Pharmaceutical has received priority review from...

June 22, 2010

The Food and Drug Administration has granted orphan drug designation to an investigational treatment for...

June 17, 2010

The Food and Drug Administration has approved a drug as an early treatment for a...